A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies

• Sponsor: Samyang Biopharmaceuticals Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01103791
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 6
• Actual Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Malignancies	Drug: Docetaxel-PNP	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies
• Actual Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Docetaxel-PNP 20mg/m2	Drug: Docetaxel-PNP; Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 2 Docetaxel-PNP 35mg/m2	Drug: Docetaxel-PNP; Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 3 Docetaxel-PNP 45mg/m2	Drug: Docetaxel-PNP; Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 4 Docetaxel-PNP 60mg/m2	Drug: Docetaxel-PNP; Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 5 Docetaxel-PNP 75mg/m2	Drug: Docetaxel-PNP; Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 6 Docetaxel-PNP 90mg/m2	Drug: Docetaxel-PNP; Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel

Outcome Measures

Primary Outcome Measures

1. The maximum tolerated dose (MTD) of Docetaxel-PNP [up to 6 cycle]

   Administration of docetaxel-PNP was well tolerated up 6mg/m² every 3weeks by heavily pretreated patients.

2. The recommended phase II dose of Docetaxel-PNP [up to 6 cycle]

   Futher phase Ⅱ Trials are recommended at this dose level

Secondary Outcome Measures

1. The Dose Limiting Toxicity (DLT) [up to 6 cycle]

2. The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss) [up to 6 cycle]

3. Objective response rate [up to 6 cycle]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient ages more than 18 years old

• Patient should voluntarily sign a written informed consent before study entry

• Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria

• Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective

• Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy

• Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• Patient has a life expectancy of at least 3 months

• Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following:

• Hb ≥ 10g/dl

• ANC ≥ 1.5 X 109/L

• Platelet count ≥ 100 X 109/L

• Serum total bilirubin ≤ 1.5 mg/dL

• Serum AST and ALT ≤ 2.5 X UNL

• Serum ALP ≤ 2.5ⅹUNL

• Serum creatinine ≤ 1.5 X UNL

Exclusion Criteria:

• Patient has had a major surgery except tumor ablation within 2 weeks before screening visit

• Patient has a brain metastasis with neurologic symptom

• Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE

• Patient has any serious concurrent disease such as:

Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.

• Patient has hypersensitivity to the Investigational product or their excipients

• Patient has participated in any other clinical trial within 4 weeks before screening visit

• Woman is pregnant or breast feeding

• Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:

• Barrier method with spermicide

• Intrauterine device

• Complete abstinence, etc.

• Patient who has a history of resistance, intolerance, or no response to Docetaxel therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samyang Biopharmaceuticals Corporation

Investigators

• Principal Investigator: Kyung Hae Jung, Ph. D., Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samyang Biopharmaceuticals Corporation
• ClinicalTrials.gov Identifier: NCT01103791
• Other Study ID Numbers: DOPNP101
• First Posted: Apr 15, 2010
• Last Update Posted: May 5, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Neoplasms; Docetaxel

Study Results

No Results Posted as of May 5, 2017